Hypoplastic Left Heart SyndromeNCT01215240
Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
A study testing Peritoneal dialysis in people with Hypoplastic Left Heart Syndrome, run by University of Alberta at 1 site in Canada.
Trial summary
Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- What is being tested?
- Peritoneal dialysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with HLHS or its variants who have a Norwood procedure
- Parental consent
Who cannot join
- Premature neonates less than 37 weeks gestation
- Weight less than 2 kg
- Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
- Pre-operative renal replacement therapy
- Abdominal defects precluding placement of a PD catheter
- Known chromosomal abnormality
- Pre-operative cardiopulmonary resuscitation (CPR)
- Pre-operative extra-corporeal life support (ECLS)
Trial locations and contacts
1 site in 1 country.
About this study
Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.
Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.
- Conditions
- Hypoplastic Left Heart Syndrome
- Being tested
- Peritoneal dialysis
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysisDevice
Prophylactic peritoneal dialysis
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic peritoneal dialysis | Experimental | Prophylactic peritoneal dialysis Receives: Device: Peritoneal dialysis |
| Standard care without PDC | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Post-operative Negative 24 Hour Fluid Balance
Time to first post-operative negative fluid balance which occurred in first 72 hrs
Measured: up to 72 hours
Secondary outcomes (5)
Time to Sternal Closure
Measured: Up to 200 hours
Time to Lactate Less Than or Equal to 2mmol/L
Time to lactate less than or equal to 2mmol/L typically occurred in first 24 hrs
Measured: From time of admission in PICU until assessment was reached, assessed up to 24 hours
Time to First Extubation
Measured: Up to 15 days
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
The maximum VIS assessed from days 2-5 will be chosen. A total VIS score is reported; there are no subscales. Minimum VIS is 0 (there are no units to VIS). Maximum VIS could be 100 but numbers are more typically 5-40. Higher VIS represent more inotropic support and potentially worse outcomes.
Measured: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
Hospital Length of Stay
Measured: Assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Principal investigator, Lindsay Ryerson, University of Alberta
- Investigators
- Lindsay M Ryerson, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215240
- Sponsor's protocol ID
- 2010-LR-001
- Status last verified
- Aug 2019
- First submitted
- 4 Oct 2010
- Last updated
- 2 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ryerson LM, Mackie AS, Atallah J, Joffe AR, Rebeyka IM, Ross DB, Adatia I. Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):222-8. doi: 10.1016/j.jtcvs.2014.08.011. Epub 2014 Aug 13.
PubMed 25218539
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Peritoneal Dialysis Decreases Time to Achieve a Negative Fluid Balance After the Norwood Procedure
- ClinicalTrials.gov ID
- NCT01215240
- Acronym / sponsor ID
- 2010-LR-001
- Conditions
- Hypoplastic Left Heart Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Study start
- Sep 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Babies born with hypoplastic left heart syndrome (HLHS) have three separate, complex heart surgeries before they turn three years of age. The first surgery typically happens in the first two weeks of life. After this operation, babies come back to the intensive care unit with their chests open. Babies who have heart surgery retain body water after surgery and this extra water slows recovery. Surgeons cannot close the chest until the baby gets rid of the extra water. As a result, babies have to stay in the intensive care unit and on a breathing machine for longer.
Peritoneal dialysis, also known as PD, involves placing a small catheter into the belly cavity at the time of surgery. PD helps the kidney to get rid of extra body water. PD involves putting small amounts of special fluid into the belly through the catheter. This special fluid attracts water and is drained hourly. By allowing the belly cavity to drain, this helps both the heart and the lungs. This allows the chest to be closed and the breathing tube to be removed. The investigators are looking to see how quickly the babies, with and without PD, get rid of the extra water in turn shortening their stay in the intensive care unit and in the hospital. PD is not permanent, and only used for the first few days after the operation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects randomized to peritoneal dialysis catheter (PDC) or no PDC and standard care.
| Arm | Type | Receives |
|---|---|---|
| Prophylactic peritoneal dialysis | Experimental | Device: Peritoneal dialysisProphylactic peritoneal dialysis |
| Standard care without PDC | No intervention | – |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants with HLHS or its variants who have a Norwood procedure
- Parental consent
Key exclusion criteria (8 listed)
- Premature neonates less than 37 weeks gestation
- Weight less than 2 kg
- Urine output less than 0.5ml/kg/hr over 24 hours in the 48 hours prior to the Norwood
- Pre-operative renal replacement therapy
- Abdominal defects precluding placement of a PD catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal dialysisProphylactic peritoneal dialysis | Device | Prophylactic peritoneal dialysis |
Primary outcome
Time to First Post-operative Negative 24 Hour Fluid Balance
Time frame: up to 72 hours
Time to first post-operative negative fluid balance which occurred in first 72 hrs
5 secondary outcomes
Time to Sternal Closure
Time frame: Up to 200 hours
Time to Lactate Less Than or Equal to 2mmol/L
Time frame: From time of admission in PICU until assessment was reached, assessed up to 24 hours
Time to First Extubation
Time frame: Up to 15 days
Maximum Vasoactive Inotrope Score (VIS) on Post-operative Days 2-5
Time frame: Assessed at days 2, 3, 4 and 5 with the highest score from those 4 days reported
Hospital Length of Stay
Time frame: Assessed up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25218539Ryerson LM, Mackie AS, Atallah J, Joffe AR, Rebeyka IM, Ross DB, Adatia I. Prophylactic peritoneal dialysis catheter does not decrease time to achieve a negative fluid balance after the Norwood procedure: a randomized controlled trial. J Thorac Cardiovasc Surg. 2015 Jan;149(1):222-8. doi: 10.1016/j.jtcvs.2014.08.011. Epub 2014 Aug 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lindsay M Ryerson, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal dialysis in people with Hypoplastic Left Heart Syndrome, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Post-operative Negative 24 Hour Fluid Balance (time frame: up to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01215240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.